HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

NCT04904588 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ACCESS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 39

Brief Summary

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies.

Conditions

Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Mixed Phenotype Acute Leukemia; Acute Leukemia; Myelodysplastic Syndromes; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Lymphoma

Keywords

Lymphoma; Leukemia; Hematologic Diseases; Myelodysplastic Syndromes; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Acute; Leukemia, Biphenotypic, Acute; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Precancerous Conditions; Leukemia, Lymphoid; Leukemia, B-Cell; Leukemia, Myeloid; Cyclophosphamide; Mesna; Tacrolimus; Busulfan; Fludarabine; Total Body Irradiation; Melphalan; Mycophenolate mofetil; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Hematopoietic Stem Cell Transplantation; Unrelated Donors

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  1 year post HCT

Secondary Outcomes (20)

• Event-free survival

  1 year post-HCT

• GVHD, relapse free survival

  1 year post-HCT

• Modified GVHD, relapse free survival

  1 year post-HCT

• Progression-free survival

  1 year post-HCT

• Cumulative incidence of nonrelapse mortality

  Day +100 and 1 year post-HCT

Study Arms (7)

Regimen A (MAC: busulfan and fludarabine, PBSC HCT)

EXPERIMENTAL

Patients receive: * Busulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3 * Fludarabine (150 mg/m2 total dose) IV on days -6 to -2 Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.

Drug: Busulfan; Drug: Fludarabine; Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT); Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Regimen B (MAC: Fludarabine and TBI; PBSC HCT)

EXPERIMENTAL

Patients receive: * Fludarabine (90 mg/m2 total dose) IV on days -7 to -5 * Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1 Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Drug: Fludarabine; Radiation: Total-body irradiation; Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT); Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT)

EXPERIMENTAL

Patients receive: * Fludarabine (120-180 mg/m2 total dose) IV on days -6 to -2 * Busulfan (less than or equal to 8 mg/kg PO or 6.4 mg/kg IV) on days -5 and -4 Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Drug: Busulfan; Drug: Fludarabine; Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT); Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT)

EXPERIMENTAL

Patients receive: * Fludarabine (120-180 mg/m2 total dose) IV on days -7 to -3 * Melphalan (100-140 mg/m2) IV on day -1 Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Drug: Fludarabine; Drug: Melphalan; Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT); Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)

EXPERIMENTAL

Patients receive: * Fludarabine (150 mg/m2 total dose) IV on days -6 to -2 * Cyclophosphamide (29-50 mg/kg) IV on days -6 and -5 * TBI (200 cGy) on day -1 Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Drug: Fludarabine; Radiation: Total-body irradiation; Drug: Cyclophosphamide; Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT); Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT)

EXPERIMENTAL

Patients receive: * Busulfan (dosed by age and weight per institutional standards to target goal pharmacokinetic (PK) in range noted in protocol.) on days -6 to -3 * Cyclophosphamide (100 mg/kg total dose) IV on days -2 and -1 Patients receive a bone marrow (BM) graft infusion from a mismatched unrelated donor on Day 0.

Drug: Busulfan; Drug: Cyclophosphamide; Procedure: Bone Marrow Hematopoietic Stem Cell Transplantation; Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

EXPERIMENTAL

Patients receive: * Cyclophosphamide (100 mg/kg total dose) IV on days -5 and -4 * TBI (1200 cGy total dose) on days -3, -2 and -1 Patients receive a BM graft infusion from a mismatched unrelated donor on Day 0.

Radiation: Total-body irradiation; Drug: Cyclophosphamide; Procedure: Bone Marrow Hematopoietic Stem Cell Transplantation; Drug: Post-transplant Cyclophosphamide; Drug: Mesna; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Other: Patient-Reported Outcomes

Interventions

Busulfan DRUG

Given IV or PO pre-transplant as part of conditioning regimen

Also known as: Busulfex®

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT)

Fludarabine DRUG

Given IV pre-transplant as part of conditioning regimen

Also known as: Fludara®

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)

Total-body irradiation RADIATION

Administered pre-transplant as part of conditioning regimen

Also known as: TBI

Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Cyclophosphamide DRUG

Given IV pre-transplant as part of conditioning regimen

Also known as: Cytoxan®

Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Melphalan DRUG

Given IV pre-transplant as part of conditioning regimen

Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT)

PBSC Hematopoietic Stem Cell Transplantation (HSCT) PROCEDURE

Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.

Also known as: PBSC HSCT, PBSC HCT, PBSC Transplantation

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)

Bone Marrow Hematopoietic Stem Cell Transplantation PROCEDURE

Bone marrow graft is infused from a mismatched unrelated donor on Day 0.

Also known as: BM HSCT, BM HCT, Bone Marrow Transplantation

Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Post-transplant Cyclophosphamide DRUG

Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.

Also known as: Cytoxan®

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Mesna DRUG

Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.

Also known as: Mesnex®

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Tacrolimus DRUG

Tacrolimus is given at a dose of 0.05 mg/kg PO or an IV dose of 0.03 mg/kg of ideal body weight (IBW) starting on Day +5 post-transplant with taper recommended at 90-100 days post HCT.

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Mycophenolate Mofetil DRUG

Mycophenolate mofetil (MMF) is given at a dose of 15 mg/kg three times daily IV or PO from Day +5 to Day +35 post-transplant.

Also known as: MMF, Cellcept®

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Patient-Reported Outcomes OTHER

Survey assessments will be administered to study participants pre- and post-transplant.

Regimen A (MAC: busulfan and fludarabine, PBSC HCT); Regimen B (MAC: Fludarabine and TBI; PBSC HCT); Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT); Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT); Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT); Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT); Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 66 years (chemotherapy-based conditioning) or \< 61 years (total body irradiation \[TBI\]-based conditioning) at the time of signing informed consent
• Planned MAC regimen as defined per protocol
• Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age \< 35 years
• Product planned for infusion is PBSC
• HCT Comorbidity Index (HCT-CI) \< 5
• One of the following diagnoses:
• Acute myeloid leukemia (AML) acute lymphoblastic leukemia (ALL), or other acute leukemia in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extra-medullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.
• Patients with myelodysplastic syndrome (MDS) with no circulating blasts and with \< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% or 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.
• Cardiac function: Left ventricular ejection fraction \> 45% based on most recent echocardiogram or multigated acquisition scan (MUGA) results
• Estimated creatinine clearance \> 60 mL/min calculated by equation
• Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin \> 50% and forced expiratory volume in first second (FEV1) predicted \> 50% based on most recent pulmonary function test results
• Liver function acceptable per local institutional guidelines
• Karnofsky performance status (KPS) of \> 70%
• Subjects ≥ 18 years of age or legally authorized representative must have the ability to give informed consent according to applicable regulatory and local institutional requirements.
• Age \> 18 years at the time of signing informed consent

You may not qualify if:

• Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
• Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
• Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera, or MDS with grade 4 marrow fibrosis
• Subjects with a prior allogeneic HSC transplant
• Subjects with an autologous HSC transplant within the past 3 months
• Females who are breast-feeding or pregnant
• Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
• Concurrent enrollment on other interventional GVHD clinical trial (enrollment on supportive care trials may be allowed after discussion with Principal Investigators)
• Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant.
• Patients who are HIV+ with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Donor unwilling or unable to donate
• Recipient positive anti-donor HLA antibodies against a mismatched HLA in the selected donor determined by the presence of donor specific HLA antibodies (DSA) to any mismatched HLA allele/antigen at any of the following loci (HLA-A, -B, -C, -DRB1, DRB3, DRB4, DRB5, -DQA1, -DQB1, -DPA1, -DPB1) with median fluorescence intensity (MFI) \>3000 by microarray-based single antigen bead testing. In patients receiving red blood cell or platelet transfusions, DSA evaluation must be performed or repeated post-transfusion and prior to donor mobilization and initiation of recipient preparative regimen.

Sponsors & Collaborators

• Center for International Blood and Marrow Transplant Research: lead
• National Marrow Donor Program: collaborator

Study Sites (39)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory University Medical Center

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Medical Center - Mott Children's Hospita

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Ohio State Medical Center, James Cancer Center

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

TriStar BMT

Nashville, Tennessee, 37203, United States

Location

TriStar Medical Group Children's Specialists

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

-Baylor College of Medicine - Texas Children's Hospital and Houston Methodist

Houston, Texas, 77030, United States

Location

Texas Transplant Institute

San Antonio, Texas, 37203, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Wisconsin Hospital and Clinic

Madison, Wisconsin, 53792, United States

Location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Al Malki MM, Bo-Subait S, Logan B, Olson J, Kou J, Smith S, Leckrone E, Wu J, Stefanski HE, Auletta JJ, Spellman SR, Malmberg C, Askar M, Cusatis R, Shaffer BC, Modi D, Khimani F, Gooptu M, Hamadani M, Madbouly A, Maiers M, Fingerson S, Cook R, Ballen K, Loren A, Larkin K, Arai S, Qayed M, Choi SW, Broglie L, Shaw BE, Devine SM, Jimenez Jimenez AM. Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis After Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation. J Clin Oncol. 2025 Sep;43(25):2772-2781. doi: 10.1200/JCO-25-00856. Epub 2025 Jun 16.

  PMID: 40523209 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Biphenotypic, Acute; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Leukemia; Hematologic Diseases; Preleukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Precancerous Conditions; Leukemia, Lymphoid; Leukemia, B-Cell; Leukemia, Myeloid

Interventions

Busulfan; fludarabine; fludarabine phosphate; Whole-Body Irradiation; Cyclophosphamide; Melphalan; Peripheral Blood Stem Cell Transplantation; Bone Marrow Transplantation; Mesna; Tacrolimus; Mycophenolic Acid; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Radiotherapy; Therapeutics; Investigative Techniques; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative; Tissue Transplantation; Sulfhydryl Compounds; Macrolides; Lactones; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Steven Devine, MD

  NMDP/Be The Match

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: September 30, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)